Remove p applicant Novo
article thumbnail

Leading innovators in glycoside hydrolase-based drug compositions for the pharmaceutical industry

Pharmaceutical Technology

Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely. By means of geographic reach, Amicus Therapeutics holds the top position, while F.

Drugs 130
article thumbnail

So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 807, Subpart E), De Novo authorization (21 C.F.R. By Adrienne R. Part 860 Subpart D), or PMA approval (21 C.F.R.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Discounts Available! Submit a Small Business Certification Request Today for a Reduced Medical Device User Fee

FDA Law Blog

Industry agrees to fee collections in exchange for FDA commitments to meet certain performance goals, such as reaching a decision on a marketing application within a predictable timeline. The user fees, however, do not correlate to the review outcome for the application. First application submission fee waiver. Our Observations.

Sales 59
article thumbnail

Combating antimicrobial resistance with a viable alternative to traditional antibiotics

pharmaphorum

Healthcare executive with 29-years of Biopharmaceutical experience working with Global leaders such as Abbott, Novo Nordisk and AbbVie. In his most previous role, he led the turn-around of the Novo Nordisk business in Europe to deliver double digit growth after 15 years of no growth and market shares losses. Herpers, P.

Bacteria 104
article thumbnail

What to expect from PEGS Europe 2023: Day 2

Drug Discovery World

Gail Calvert, Field Application Scientist, Sartorius UK, on: ‘Leveraging integrated and advanced technologies for successful cell line development’. The luncheon presentations include: Juan Quintana, PhD, Technical Sales Manager, ACROBiosystems, on: ‘Manufacturing high quality proteins for complex applications’. Filip Borgions, Ph.D,

article thumbnail

Democratising proteomics for cancer and beyond

Drug Discovery World

The applications for this technology are varied. Target discovery then is a key application for Nautilus. DDW Volume 24 – Issue 2, Spring 2023 References Wang P, Wilson SR. Mass spectrometry-based protein identification by integrating de novo sequencing with database searching. BMC Bioinformatics. Epub 2013 Jan 21.

Protein 52
article thumbnail

Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

Álvarez-Castro P, Pena L, Cordido F. Avena NM, Bocarsly ME, Rada P, Kim A, Hoebel BG. Avena NM, Rada P, Hoebel BG. Basu S, Yoffe P, Hills N, Lustig RH. Colantuoni C, Rada P, McCarthy J, Patten C, Avena NM, Chadeayne A, Hoebel BG. Leptin applications in 2015: What have we learned about leptin and obesity?

Insulin 52